Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00503386
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : September 17, 2010
Sun Yat-sen University
Tigermed Consulting Co., Ltd
Information provided by:
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Brief Summary:
The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Chemotherapy Drug: Palonosetron Drug: Granisetron Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Phase II,Multicenter,Randomized,Double-blind,Cross-over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-induced Nausea and Vomiting in Asian Population
Study Start Date : April 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting) [ Time Frame: 0-24h, 24-120h , 0-120h following chemotherapy ]

Secondary Outcome Measures :
  1. Major Protection from vomiting [ Time Frame: 0-24h,24-120h,0-120h following chemotherapy ]
  2. Major Protection from nausea [ Time Frame: 0-24h,24-120h,0-120h following chemotherapy ]
  3. Complete Protection from Both Vomiting and Nausea [ Time Frame: 0-24h,24-120h,0-120h following chemotherapy ]
  4. Complete Protection from Both Vomiting and Moderate-to-Severe nausea [ Time Frame: 0-24h,24-120h,0-120h following chemotherapy ]
  5. Time to First Emetic Episode [ Time Frame: 0-120h following chemotherapy ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, age ≥ 18 yrs and <70 yrs with histologically or cytologically confirmed
  • Malignant disease
  • Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60
  • Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 ~ 80 mg/m2 on study Day 1
  • Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
  • Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion
  • Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion
  • Predicted life expectancy of ≥ 3 months
  • Provision of written informed consent.

Exclusion Criteria:

  • Inability to understand or cooperate with study procedures
  • Receipt of investigational drugs ≤ 30 days before study entry
  • Receipt of other investigational drugs during the course of this study
  • Seizure disorder or any condition requiring anticonvulsants, sedatives
  • CNS malignancy or metastasis
  • Ongoing emesis due to obstruction of digestive tract
  • Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy
  • Moderate or severe nausea and vomiting after any previous chemotherapy
  • Scheduled receipt of any chemotherapeutic agent with an emetogenicity level >3 during study Days 2-5
  • Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5
  • Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5
  • Contraindications to 5-HT3 receptor antagonists
  • Contraindications to chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00503386

China, Fujian
Fujian Provincial Tumor Hospital
Fuzhou, Fujian, China, 350014
China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
China, Hunan
Hunan Provincial Tumor Hospital
Changsha, Hunan, China, 410006
China, Jiangsu
Jiangsu Provincial Tumor Hospital
Nanjing, Jiangsu, China, 210009
China, Zhejiang
The Second Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, China, 310009
Beijing Institute on Thoracic Cancer and Tuberculosis
Beijing, China, 101149
Sponsors and Collaborators
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Sun Yat-sen University
Tigermed Consulting Co., Ltd
Principal Investigator: Tongyu Lin, M.D. Sun Yat-sen University

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00503386     History of Changes
Other Study ID Numbers: HJGene_SYat-sen_06_01
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: September 17, 2010
Last Verified: September 2010

Keywords provided by Hangzhou Jiuyuan Gene Engineering Co. Ltd.,:
chemotherapy-induced nausea and vomiting
5-HT3 receptor antagonist

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents